MAUDE Adverse Event Report: TELEFLEX MEDICAL VCLUDE TI S 6/CART 30/BOX; CLIP, IMPLANTABLE

Model Number IPN055281

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 01/27/2023

Event Type  Injury  

Event Description

Reported issue: we had an incident 10 days ago while doing an av fistula that a blue ligation clip was applied to the vessel and it severed the vessel causing it to retract and increased the bleeding to the arm.

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.This is linked to report 3011137372-2023-00026 and 3011137372-2023-00060.We received additional clips samples without lot numbers.

Event Description

Reported issue: we had an incident 10 days ago while doing an av fistula that a blue ligation clip was applied to the vessel and it severed the vessel causing it to retract and increased the bleeding to the arm.

Manufacturer Narrative

(b)(4).The customer returned one cartridge of 40425s vclude ti med 24/cart 25/box and two 70462 vclude aplr med cvd 6" 152mm appliers for i nvestigation.The cartridge and appliers were examined with and without magnification.Visual examination of the cartridge revealed obvious signs of use in the form of biological material.There were twenty-two clips remaining in the cartridge.Both appliers were misaligned.In an attempt to replicate the reported failure, functional inspection was performed on the 22 remaining clips using the returned 70462 vclude aplr med cvd 6" 152mm appliers.All 22 clips from the returned cartridge were able to load properly into the returned appliers and was able to be applied to over-stressed surgical tubing.The reported defect could not be replicated based upon the sample returned.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu for this product states: "remove the applier from cartridge and verify that the clip legs do not protrude beyond the end of the jaws.The clip should be seated firmly." "avoid premature closure of the applier jaws which can cause a clip to partly close and slip back." "user to establish unobstructed application site visibility and confirm location of clip placement prior to applying clip.User should not twist applier on vessel to gain visibility." "at the surgical site the surgeon should close the applier ring handles with a smooth, firm, continuous motion until the clip is fully closed.Releasing the pressure on the ring handles will cause the applier jaws to spring open." "appliers are precision instruments and must be handled with care.Inspect for wear or damage and confirm adequate clip pick-up prior to use.Return to vesocclude medical, llc, llc for repair as necessary.If not done a patient injury could occur." "always check the alignment of applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury could occur." "inspect instruments after each sterilization cycle and prior to each use as they may be damaged during transit to the customer, during receiving at the customer's site, during use in a previous procedure or during the cleaning or sterilization processes.All moving parts must be inspected for wear and confirmed to be functional.Confirm smooth operation during opening and closing of instrument handle and reinforcing screw." "inspect instruments for rust, pitting, cracking or burrs, staining or discoloration, and worn or broken parts.Repair or replace any instru ment found not to be acceptable." "do not use an instrument with broken, cracked or worn parts." the customer complaint could not be confirmed.Visual examination revealed obvious signs of use in the form of biological material.There were 22 clips remaining in the cartridge.A dhr review was performed on the potential lot number of the returned cartridge and no relevant findings were identified.Functional inspection was performed on the 22 remaining clips using the returned appliers.All 22 clips from the returned cartridge was able to load properly into the returned appliers and was able to be applied to over-stressed surgical tubing.The ifu for this product states "always check the alignment of applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury could occur." "appliers are precision instruments and must be handled with care.Inspect for wear or damage and confirm adequate clip pick-up prior to use.Return to vesocclude medical, llc, llc for repair as necessary.If not done a patient injury could occur." teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: VCLUDE TI S 6/CART 30/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16496660
• MDR Text Key: 310809068
• Report Number: 3011137372-2023-00061
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704666670
• UDI-Public: 24026704666670
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN055281
• Device Catalogue Number: 40425S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED
• Patient Outcome(s): Required Intervention; Hospitalization